(Operating Qualification)

MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT ------------------------------------------------------------------------------------------------------------------

VIBRO SIFTER  30” DIA. (GMP MODEL) OPERATING QUALIFICATION M/s. Milan Laboratories India Pvt. Ltd,

CLIENT PARTY’S REF. (P.O) NO. MONTH & YEAR OF MFG.

2009-2010

LOCATION

Panvel

OUR REF. NO. JOB NO.

521006

MODEL NO.

30VS

 Allied  MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT 

Unit No. 17, Param Industrial Estate, Naik Pada, Waliv, Vasai (East), District Thane- 401 208, Maharashtra, India. Fax: 0250 –: 2451675 2451675  Tel : 6451697, 6454301, 2451674

MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT

PROTOCOL APPROVAL COVER PAGE

The signatures below indicate approval of this protocol. Once signatures are obtained, execution of the protocol may begin. Department

Authorized Person

Signature

Date

Initiated by

Reviewed by Approved by

CONTENTS Sr. No. 1.0 2.0 3.0 4.0 4.0 5.0 5.1 5.2 5.3 5.4 6.0 6.0 7.0

TITLE

Introduction Rationale Responsibilities Equip quipme ment nt Crit Critic ical al to Study tudy Qualification Description Prerequisites Start Up Emergency Stop Power Failure Crit Criter eria ia For For Acc Accep epta tabi bili lity ty Conclusion OQ Data Sheets Operational Qualification Approval Page

1.0

2.0 2.0

INTRODUCTION

1.1

The object objective ive of this this Protocol Protocol is to provide provide guide guideline lines s for the instal installatio lation n of the Vibro Sifter.

1.2

Insta Installa llatio tion n deta details ils for the Vibro Vibro sifte sifterr are availab available le in installa installatio tion n quali qualific ficati ation on Protocol (II/PP/RPT/QUA/18). The operation of the equipment is described in the SOP titled operation of Vibro sifter SOP No. II/PP/SOP/OPR/3

1.3 1.3

The The obje object ctiv ive e of this this stud study y is to asse assess ss the abili ability ty of the the sift siftin ing g equi equipm pmen entt to operate correctly as per the designed parameters. The study will also assess the electrical operations.

RATI RATION ONAL ALE E FOR FOR QUAL QUALIF IFIC ICAT ATIO ION N PROG PROGRA RAMM MME E Page 2

MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT

The sifter functions by imparting vibratory energy to the granules in the bowl by means vibrating motor. The amount of energy imparted is proportional to the motor speeds. These functions of the equipment will be challenged within the anticipated operational limits. Also, all electrical and sealing operations of the equipment equipment shall be qualified. qualified. The equipment equipment will be validated for the following functions in manual and auto mode: 2.1 Critical operating parameters: 2.1.1 Leakage 2.1.2 Material movement 2.1.3 Vibration. 2.2 Power Failure 3.0

RESPONSIBILITIES

3.1

The The respo responsi nsibil bility ity of of the Vali Valida datio tion n Team Team is overa overall ll adhe adheren rence ce to this this proto protoco col. l. Specific duties include: 3.1.1 3.1.1 3.1.2 3.1.2 3.1.3 3.1.3 3.1.4 3.1.4 3.1.5 3.1.5 3.1. 3.1.6 6

3.2 3.2

The The resp respon onsi sibi bili lity ty of of the the Q.A. Q.A. Dep Depar artm tmen entt incl includ udes es:: 3.2.1 3.2.1 3.2. 3.2.2 2 3.2.3 3.2.3

3.3

Monitorin Monitoring g Protocol Protocol comple completene teness, ss, accuracy accuracy,, technical technical excelle excellence nce and applicability. Scheduli Scheduling ng and and Opera Operation tional al Qualif Qualificat ication ion activ activity ity Maintena Maintenance nce and and calibra calibration tion of of validati validation on equip equipmen mentt Conducti Conducting ng the the Opera Operation tional al Qualif Qualificat ication ion activity activity Data review review of of valida validation tion Protocol Protocol preparati preparation on Appr Approv oval al of Prot Protoc ocol ol

Issue Issue validat validation ion data data shee sheett to the the valid validatio ation n team team Revi Review ew of of vali valida dati tion on dat data a Appro Approval val of val valida idatio tion n Prot Protoc ocol ol

The The respo responsi nsibil biliti ities es of of Form Formula ulatio tion n Deve Develop lopme ment nt are are as as follo follows: ws:

3.3. 3.3.1 1 To make make crit critic ical al equi equipm pmen entt avai availa labl ble e for for vali valida dati tion on.. equipment is listed in Section 4 of this protocol) 3.3.2 3.3.2 Review Review of of data data and and appro approva vall of Proto Protoco coll 3.4 3.4

(The (The

Exce Except ptio iona nall Cond Condit itio ions ns and and Dev Devia iati tion ons s Any minor changes or deviations that are necessary to comply with this protocol will be docume documented nted in the final final Protoco Protocol. l. Any significa significant nt changes changes or deviations deviations altering the scope or intent of this protocol require prior approval by the original signatories and documentation in the final Protocol.

4.0

EQUIPME IPMENT NT CRITIC ITICAL AL TO STU TUD DY 4.1 4.1 Cali Calibr brat ated ed Stop Stopwa watc tch h (ta (tag g no no IIE IIE 29) 29) 4.2 4.2 Cali Calibr brat ated ed Tech Techno nome mete terr (tag (tag no. no. IIE IIE 30) 30) 4.3 Vibro ibro Sifte ifterr (T (Tag no IIE - 55)

5.0

QUALIFICATION PR PROGRAMME Page 3

MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT

5.1

Prerequisites 5.1.1 5.1.1 5.1.2 5.1.2 5.1.3 5.1.3

5.1.4 5.1.4

5.2

Confirm Confirm that the equipm equipment ent/syst /system em is installed installed,, the Installatio Installation n Qualificat Qualification ion completed and installation package approved, and is ready for operation. Confirm Confirm that that the operati operating ng SOP exists exists,, in draft or approv approved ed form, form, to support support operational testing. Verify Verify that all instrume instruments nts associat associated ed with this equipm equipment/ ent/syst system, em, includi including ng those to be used for testing, have been calibrated and that the re-calibration dates will not expire before execution of this protocol has been completed. Verify Verify that all all material materials s and test test equipme equipment nt are availa available ble for the the executio execution n of  this Protocol.

Start-Up 5.2.1 5.2.1 Ensure Ensure that that the the main main electric electrical al suppl supplies ies are are ‘ON’ ‘ON’ 5.2.2 5.2.2 Switch Switch ‘ON’ ‘ON’ the the power power at at the the main main switch switch cabin cabinet. et. 5.2.3 5.2.3 Ensure Ensure that that equi equipme pment nt is cleaned cleaned before before opera operation tion.. 5.2.4 5.2.4 Checks Checks tha thatt sievin sieving g scree screen n fits fits prope properly rly.. 5.2.5 5.2.5 Ensur Ensure e that that all all gaske gaskets ts are are clo closed sed.. 5.2.6 5.2.6 Ensure Ensure that that mater material ial moves moves in circul circulatio ation n motion motion 5.2.7 5.2.7 Start Start the siftin sifting g opera operatio tion n 5.2.8 5.2.8 Run the the mac machin hines es for 30 mins. mins. ACCEPTANCE CRITERIA: All operations should be smooth.

5.3

Noise Generation 5.3.1 5.3.1 Run the the Vibro Sifter Sifter for for some time time and obser observe ve for genera generation tion of of noise. noise. ACCEPTANCE CRITERIA: No noise generation.

5.4

Direction of of Ro Rotation 5.4.1 5.4.1 check check the direct directio ion n of of moto motor  r 

5.5

Seals 5.5.1 5.5.1 Visually Visually check check for leaks leaks from top lid lid and and top top deck. deck. 5.5.2 5.5.2 Visua Visually lly che check ck for for leaks leaks from from ‘C’ ‘C’ Clam Clamp. p. ACCEPTANCE CRITERIA: No leakage

6.0

CRITE ITERIA FOR ACCEPT CEPTA ABIL BILITY ITY The Operations Qualification of Vibro Sifter shall be considered acceptable if individual operating operating parameters fall within anticipated anticipated acceptable acceptable limits. If the results do not meet anticipated acceptance limits, the review team shall meet and agree corrective actions.

7.0

CONCLUSION The collected data shall be analyzed, evaluated and reviewed against the acceptable limits limits for opera operatio tion. n. The The concl conclus usion ions s shall shall be drawn drawn based based on review review of data and suggestions shall be made to optimize the operational efficiency of equipment.

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MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT

OQ DATA SHEETS IDENTIFICATION OF PERSONNEL PERFORMING OPERATIONAL QUALIFICATION

DEPARTMENT

SIGNATURE

DATE

OQ DATA SHEET

STEP

REQUIRED

RECORDED

ACCEPTANCE CRITERIA

5.1.1

Confirm equipment / system installed, I.Q. complete and ready for  operation.

IQ documents reviewed and approved.

5.1.2

Confirm SOP exists

SOP exists

5.1.3

5.1.4

Confirm instruments calibrated and recalibration date not expired. Verify all materials and test equipment available

All instruments calibrated.

Test equipments available

5.1.5

Verify electrical supplies are “ON”

All utilities available in right capacity.

5.1.6

Verify equipment cleaning

Should be cleaned

5.1.7

Sieving screen Should not generate noise from damp and feed hopper 

Fits properly

5.1.8 5.1.9

5.1.10

 No noise

Material should move in circulation direction

Material movement in circulation direction

Continuous material movement through discharge chute

Material moves out of  discharge chute continuously

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MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT

OPERATIONAL QUALIFICATION APPROVAL PAGE OBSERVATION:

CONCLUSION:

SUGGESTION:

_________________ PREPARED BY:

(Formulation Technologist)

_________________ REVIEWED BY:

_________________  APPROVED BY:

(Manager Formulation Development) (Quality Assurance Dept)

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